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Promoting Recovery Optimization With WALKing Exercise After Stroke (PROWALKS)

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ClinicalTrials.gov Identifier: NCT02835313
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : May 18, 2017
Sponsor:
Collaborators:
University of Pennsylvania
Christiana Care Health Services
Information provided by (Responsible Party):
University of Delaware

Brief Summary:
Stroke survivors, as a group, are extremely inactive and this has serious consequences for them, including an increased risk of a second stroke and developing other diseases. This study investigates a novel intervention designed to improve everyday activity after stroke by combining walking training to improve walking capacity with a program to encourage more daily walking.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: FAST Behavioral: FAST+SAM Behavioral: SAM Phase 2 Phase 3

Detailed Description:
As a group, stroke survivors are more physically inactive than even the most sedentary older adults. Lack of physical activity has serious consequences in persons with stroke, including an increased risk of recurrent stroke, developing other diseases and mortality. Current rehabilitation interventions do little to improve real-world walking activity after stroke, suggesting that simply improving walking capacity is not sufficient for improving daily physical activity after stroke. Rather, the investigator's hypothesize that the combination of a fast walking intervention that improves walking capacity, with a step activity monitoring program that facilitates translation of gains from the clinic to the "real-world", would generate greater improvements in real world walking activity than with either intervention alone. Data from the investigator's lab provides support for this hypothesis; however, it suggests that the greater efficacy of combining the 2 interventions depends on a participant's initial walking activity. Thus, the investigator's do not expect that one intervention will be superior to the others for all participants, but rather that the combined intervention will be superior for those with low levels of baseline walking activity, speed and endurance. The specific objective of this study is to test whether and for whom combining fast walking training with a step activity monitoring program (FAST+SAM) is superior in improving real-world walking activity compared to fast walking training alone (FAST) or a step activity monitoring and feedback program alone (SAM) in those with chronic stroke. Using a randomized controlled experimental design, 225 chronic (> 6 months) stroke survivors, will complete 12 weeks of fast walking training (FAST), a step activity monitoring program (SAM) or a fast walking training + step activity monitoring program (FAST+SAM). Moderation of specific intervention outcomes by baseline characteristics will be evaluated to determine for whom the interventions are effective.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: FAST+SAM
Subjects participate in fast walking training in combination with a step activity monitoring program
Behavioral: FAST+SAM
Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks

Active Comparator: FAST
Subjects participate in fast walking training
Behavioral: FAST
Subjects participate in fast walking training 3x/week for 12 weeks.

Active Comparator: SAM
Subjects participate in a step activity monitoring program
Behavioral: SAM
Subjects participate in a step activity monitoring program 3x/week for 12 weeks




Primary Outcome Measures :
  1. Steps per day [ Time Frame: Change in steps per day from pre-intervention to 12 months later ]

Secondary Outcome Measures :
  1. walking speed as measured by the 10 meter walk test [ Time Frame: Change in walking speed from pre-intervention to 12 months later ]
  2. endurance as measured by the 6 minute walk test [ Time Frame: Change in endurance from pre-intervention to 12 months later ]
  3. oxygen consumption [ Time Frame: Change in oxygen consumption from pre-intervention to 12 months later ]


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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 21-85
  2. Chronic stroke (>6 months post stroke)
  3. Able to walk at self-selected speed without assistance from another person (assistive devices are allowed)
  4. Self-selected walking speed >0.3 m/s and <1.0 m/s
  5. Average steps/day <8,000
  6. Resting heart rate between 40-100 beats per minute
  7. Resting blood pressure between 90/60 to 170/90.

Exclusion Criteria:

  1. Evidence of cerebellar stroke
  2. Other potentially disabling neurologic conditions in addition to stroke
  3. Lower limb Botulinum toxin injection <4 months earlier
  4. Current participation in physical therapy
  5. Inability to walk outside the home prior to the stroke
  6. Coronary artery bypass graft, stent placement or myocardial infarction within past 3 months
  7. Musculoskeletal pain that limits activity
  8. Inability to communicate with investigators
  9. score >1 on question 1b and >0 on question 1c on the NIH Stroke Scale.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835313


Contacts
Contact: Darcy Reisman, PT, PhD 302-831-0508 dreisman@udel.edu

Locations
United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States, 19712
Contact: Darcy Reisman, PT, PhD    302-764-4701    dreisman@udel.edu   
Sponsors and Collaborators
University of Delaware
University of Pennsylvania
Christiana Care Health Services
Investigators
Principal Investigator: Darcy Reisman, PT, PhD University of Delaware

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Delaware
ClinicalTrials.gov Identifier: NCT02835313     History of Changes
Other Study ID Numbers: NIH 1R01HD086362-01A1
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be deposited in the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) repository.

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases